FDA to Recognize Inspections from EU Drug Authorities

Oct 31, 2017

By BioPharm International Editors

Effective Nov. 1, 2017, FDA will recognize the pharmaceutical drug manufacturing inspection data from eight European regulatory authorities, potentially reducing duplicate inspections by different regional authorities. In an Oct. 31, 2017 announcement, FDA reported a new policy that will enable the agency and the drug regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom to use each other’s good manufacturing practice (GMP) inspections of pharmaceutical facilities.

“At a time in which medical product manufacturing is truly a global enterprise, there is much to be gained by partnering with regulatory counterparts to reduce duplicative efforts and maximize global resources while realizing the greatest bang for our collective inspectional buck,” said FDA Commissioner Scott Gottlieb, in a statement. “By partnering with these countries, we can create greater efficiencies and better fulfill our public health goals, relying on the expertise of our colleagues and refocusing our resources on inspections in higher risk countries.”

All drugs approved in the US, including those manufactured overseas or containing foreign ingredients, must comply with applicable US regulations. Previously, FDA inspected domestic and foreign drug manufacturing plants for compliance with manufacturing standards and product label requirements.

“Beginning Nov. 1, we will take the unprecedented and significant step forward in realizing the key benefits of the Mutual Recognition Agreement with our European counterparts in that we will now rely on the inspectional data obtained by these eight regulatory agencies,” said Dara Corrigan, the FDA’s acting deputy commissioner for global regulatory operations and policy. “The progress made so far puts us on track to meet our goal of completing all 28 capability assessments in the [European Union] EU by July 2019.”

In June 2017, the European Commission determined that FDA had the capability and procedures to carry out GMP inspections at a level equivalent to the EU.

“The completion of these capability assessments enables the FDA and the EU to avoid duplication of drug inspections and allows regulators to devote more resources to other manufacturing facilities in countries where there may be greater risk,” FDA stated in the announcement. “Ultimately, this prioritization of inspections will help identify potential drug quality problems more quickly and prevent poor quality drugs from entering the US market.”